Totally Wired
22 Jul 2016
IC Article Profit from the market's Allergy reaction Megan Boxall, 21 July 2016 Using immunotherapy - stimulating the immune system - to treat allergies is rapidly gaining traction. As a scientific discipline it's not particularly new, but for a long time it has been difficult to safely and effectively revamp the body's immune system by injecting a small dose of an allergen. However, recent improvements in science, alongside increased investor interest, has carved a path for a multibillion-dollar global market and Aim-traded Allergy Therapeutics (AGY) is in an excellent position to take a slice of this. ***The content of this section is only available to Investors Chronicle online subscribers.***[link]
cloakey
13 Jul 2016
Re: Trading update revenue up 12 % with the £ weaker against the euro how do you consider this to be a `down` side
d gaser
13 Jul 2016
Trading update revenue up 12 % Things are looking good with turn over up 12% on last year .the only down side is the pound Euro exchange rates, as most of our business is done in the European union ,so hopfully it won't have a negative impct oo our net profits .BE HAPPYDAVE ,13 July 2016Allergy Therapeutics plc("Allergy Therapeutics" or the "Company"
Trading UpdateAllergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today provides a trading update for the year ended 30 June 2016 ahead of its Preliminary Results to be announced in September 2016.FinancialsReported revenues are expected to be £48.5m (2015: £43.2m), slightly ahead of current market expectations. This represents a growth of 12%* despite the negative impact from the weakening Euro during most of the year. At constant currency, this represents a growth of 19%* for the year. This solid growth has been against a flat market backdrop and has allowed the Company to increase its market share two percentage points from 10% to 12% on average across its key European markets. The main contributions in terms of market share gains for the Company have come from Germany, Austria, Spain and the UK.ProductAllergy Therapeutics' market penetration is consistent across the product portfolio, particularly from Pollinex Quattro, Oralvac (which has benefited from a competitor situation) and our newer products entering the market including Acarovac and Synbiotics. The Company expects strong revenue growth to continue for several years and aims to achieve a leading European market position in the allergoid subcutaneous immunotherapy product (SCIT) market before 2020.PipelineIn Europe, the development program for PQ Birch is on track and the Pivotal Phase III study is planned to start in H1 2017. For the US, the Company will perform another dose ranging study for PQ Grass in order to ensure that the best dose is chosen for the final Phase III study. Acarovac Quattro development is on track and initiation of Phase I studies is expected to start in H2 2016. Finally, the proof of concept study for the novel vaccine, Polyvac Peanut, is progressing according to plan.Commenting on the positive trading update, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said:
Baffler
08 Jul 2016
Better news Apart from the dosing issue announced last week or so there has been nothing negative from AGY. Dosing issues happen and as the boss said, we are confident of getting this right.Sales up 19%, that takes some doing8 July 2016 Allergy Therapeutics plc ("Allergy Therapeutics" or the "Company" Allergy Therapeutics announces publication of 1-year follow up results of its mite allergoid immunotherapy Acarovac Plus(TM) Significant decreases in symptom scores reported with Acarovac Plus Product treatment was proven to be well tolerated and safe Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces the publication of a 1-year follow-up study of patients using Acarovac Plus(TM), its unique, microcrystalline tyrosine-adsorbed, house dust mite-allergoid subcutaneous immunotherapy in the peer-review journal Immunotherapy. A previous study in 2014, led by Dr Albert Roger, Director of the Allergy Unit at Universitari Hospital Trias I Pujol, Badalona, Spain, assessed the tolerability and safety of Acarovac Plus(TM) in patients with respiratory allergy to Dermatophagoides pteronyssinus under conditions of normal clinical practice. This 1-year follow-up investigation, with the existing patient pool and testing regimen, assessed effectiveness using a nasal provocation test and measurement of immunological markers that are indicative of immunotherapy success. A statistically significant reduction in symptom scores was observed at both follow-up visits (four weeks and one year), with >50% reduction in symptom scores recorded after one year. Moreover, significant improvements in immunological markers were noted at the follow-up visits. Patients reported statistically significant improvements in satisfaction scores after one year in relation to overall effectiveness and convenience of the treatment. 2016 has seen a significant increase in sales of Acarovac Plus(TM) to over EUR 1 million in key markets Spain and Portugal, compared to 2015. Sales of house dust mite immunotherapy are expected to increase rapidly over the coming years with over 20% of the population in Europe experiencing an allergic reaction to house dust mites. Therefore, Allergy Therapeutics is continuing to develop Acarovac Quattro(TM), an ultra-short course therapy utilising the adjuvant monophosphoryl lipid A (MPL), which is used in the Company's successful Pollinex Quattro product range currently in late stage development in Europe and the US to complement Acarovac Plus(TM). Commenting on the publication, Dr Albert Roger, principal investigator for the study, said: "The successful clinical results in the 1-year follow-up study clearly demonstrate the effective treatment of house dust mite allergy by Acarovac Plus(TM). We also observed significant decreases in symptom scores and improvement in nasal sensitivity immediately after the up dosing phase of one month and a high rate of patient satisfaction early in treatment." Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "This data further reinforces the benefits of Acarovac Plus(TM) in the perennial allergy vaccine market. Using maintenance injections six weeks apart, Acarovac Plus(TM) has been shown to decrease the symptoms of house dust mite allergy one year after treatment. This dosing regime has the potential to improve the adherence and compliance that is essential for a successful treatment. Acarovac Plus(TM) bolsters our portfolio of allergy immunotherapy products on the market in Europe and we look forward to continued good growth."
d gaser
27 Jun 2016
Optimal dosing put back, FDA phase 111 trial It appears there has been a hick up in finding the high dose value for the FDA trials ,it appears the Company could not recommend an optimized dose regime to take it into a Phase III studies. .please read,RNS below D.Y.O.H BE HAPPYDAVE Allergy Therapeutics27 Jun 2016 07
09Allergy TherapeuticsRNS Number : 2800CAllergy Therapeutics PLC27 June 2016 27 June 2016 Allergy Therapeutics plc("Allergy Therapeutics" or the "Company" Allergy Therapeutics announces findings from mEEC dose range finding study G204 ~ Further dose range finding required and US plans progress with goal of being first to market ~ ~ Group's European sales accelerate at 19% growth rate ~ Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces findings from its exploratory Phase II dose-ranging study (G204) for the US GrassMATAMPL clinical development program and informs that the results did not determine a recommended dose for the Phase III trial. A further dose range finding study will be implemented prior to proceeding into the planned pivotal Phase III study. GrassMATAMPL is an ultra-short course subcutaneous allergen specific immunotherapy ("SCIT" administered prior to the grass pollen season. Based on the successful dose response data identified in the Phase II G203 study for the same US GrassMATAMPL programme, the G204 trial was designed to explore higher dose regimens using the novel technology of the mEEC (mobile environmental exposure chamber) and optimise the recommended dose before starting the pivotal Phase III trial (G306) to be performed in the US. In contrast to the G203 study, the dose range finding data with the mEEC did not allow the Company to recommend an optimised dose regime to take into Phase III studies for the US. Consequently, Allergy Therapeutics will undertake a further dose-ranging study employing the same successful European dose-finding trial design with a fixed Conjunctival Provocation Test (CPT) which provided robust results for the optimisation of the Company's marketed subcutaneous birch pollen product, Pollinex® Quattro Birch (PQBirch). The next dose range finding study is planned to start in 2017. Allergy Therapeutics will await the outcome of an End of Phase II meeting with the FDA, scheduled later in 2016, before progressing into Phase III. Commenting on the announcement, Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "Defining the optimal dose is part of late-stage product development and we will revisit dose evaluation as we recently successfully did with our PQ Birch product, using two separate and complimentary dose-ranging studies. Additionally, the new findings of our Phase II EEC study will need to be discussed with FDA before deciding on the recommended dose for the following Phase III registration trial. While still being determined to become the first company to introduce SCIT to the US, a deferred entry time into the market is now anticipated. "In Europe, our market penetration continues to accelerate, outperforming the market with 19% year-to-date revenue growth*, an increase from the 12% revenue growth* we had achieved in December 2015. "Elsewhere in the pipeline, we successfully completed a Phase IIb dose finding study for Pollinex Quattro Birch in Germany and Austria earlier this year; we've completed the exploratory dose finding study in the US; set up the protocols for the Acarovac Quattro programme in Spain; and we have initiated the proof-of-concept plan for the VLP Peanut allergy vaccine in Switzerland. "We are progressing with our plans and are very excited by the prospects of building a leading subcutaneous company in Europe as well as in international markets." *revenue growth is at constant currency and is supported by the Immunal acquisition.
Simbrad
27 Jun 2016
"This morning Allergy Therapeutics (AGY)... announced that the results from its latest phase 2 dose range finding clinical trial for GrassMATAMPL (the development version of Pollinex® Quattro Grass) were inconclusive. As a consequence, the company is not yet able to recommend a dose to take into the final phase 3 trial as expected... We estimate these events necessitate a delay of around 1 year to the start of phase 3 development for GrassMATAMPL but do not affect any other clinical development programmes being conducted by the company (i.e. the Birch vaccine phase 3 trial)." Zeus Capital note from today on research tree
Baffler
15 Jun 2016
Upbeat and full of hints - imo Allergy Therapeutics hosts Satellite Symposium at EAACI World-leading allergists present technological advances and immunotherapy innovations Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces today that data was presented in a Satellite Symposium entitled: "Adjuvants in Allergy: elevating efficacy" at the 35(th) Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI) in Vienna, Austria on 12 June 2016, relating to a number of the Company's products and technologies. Three world-leading experts in the field of allergen immunotherapy and vaccine delivery, Ralph Mösges, Randolph Brehler and Thomas Kündig, presented information on innovation in immunotherapy including Allergy Therapeutics' key product Pollinex Quattro(R). Pollinex Quattro(R)'s specialist technology was discussed, highlighting the marketed product's ability to reduce irritation and systemic reactions. Furthermore, Dr Brehler discussed how the potent depot adjuvant MCT (Micro Crystalline Tyrosine), initiated by the Company as an alternative to aluminium in subcutaneous immunotherapy and used in Pollinex Quattro(R) as well as certain other of the Company's subcutaneous injected therapies, has an immunomodulating action that augments a shift in the immune reactions responsible for the symptoms of allergic rhinitis. Data on the future role of Virus-Like-Particles (VLP) in immunotherapy was also presented as a potential new injectable vaccine immunotherapy technology. Allergy Therapeutics recently acquired an exclusive VLP technology licence and is conducting a research project on VLP-based allergy vaccines. The worldwide food allergy market is worth a potential $8bn and, currently, there is no established and safe immunotherapy treatments available for peanut allergy, the first indication the Company intends to address. Manuel Llobet, Chief Executive Officer, commented: "As a fully integrated specialty pharmaceutical company, we are delighted to be breaking new ground in allergen immunotherapy. Allergy Therapeutics has the potential to transform allergy treatment with an established range of diagnostics and specific short-course aluminium-free immunotherapy vaccines and we are well-placed to deliver the relief from symptoms of allergy that millions of patients need." Satellite Symposium: Adjuvants in Allergy: elevating efficacy 1) Ultra-short course immunotherapy, Ralph Mösges MD, PhD, MSEE, University of Cologne (Pulmonology, Allergology and Clinical Immunology) 2) Adjuvants in immunotherapy, Randolf Brehler MD, University of Münster (Allergology) 3) Future immunotherapy: virus like particles, Thomas Kündig, University Hospital Zurich (Immunology, Cell Biology and Pharmacology)
Simbrad
10 Jun 2016
scraped a bit of panmure's note from research tree: "Allergy Therapeutics has announced the appointment of Nick Wykeman (exSkyepharma) to the Board as Finance Director with immediate effect. We view today’s appointment as a solid fit, filling the position that has been open since the announcement earlier this year, with an individual whose life sciences and wider background aligns well with the Allergy business..."
Dino78
10 May 2016
TV Interview following Phase II news Morning. Quick 2 minute TV interview with Manuel following yesterday's successful Phase II announcement.www.fmp-tv.co.uk/company/allergy-therapeutics-investors-video-and-news/
Totally Wired
09 May 2016
excited by PQBirch204 Phase II data 14:25 09 May 2016 Manuel Llobet, chief executive of Allergy Therapeutics plc (LON:AGY) says the latest data from its Phase II trial of its PQBirch204 treatment for hay fever caused by birch pollen is “exciting for our company”.Allergy released the results from the latest clinical study, which assessed the response from 371 patients.The phase II trial revealed a statistically significant dose-response relationship from the groups receiving the medication, with Llobet noting the company has received “very strong top –line data”.It means the company is still on track to start the Phase III study in early 2017, and Llobet says the data is “another step towards our clinical goal to get Polinex Quattro Birch registered in Europe as soon as possible”.[link]
Totally Wired
09 May 2016
Positive Phase II Data Allergy Therapeutics announces positive top-line results from the PQBirch204 Phase II study for birch-induced seasonal allergic rhinitis · Primary endpoint met· Statistically significant dose-response relationship (p<0.01)· All dosing regimens were safe and well tolerated· Adherence was greater than 90%Allergy Therapeutics, (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces positive top-line results from the Company's PQBirch204 Phase II study, a multi-centre, double-blind, placebo-controlled study designed to explore the safety and response of different cumulative doses of Birch Modified Allergen Tyrosine adsorbed and MPL® (POLLINEX® Quattro Birch) for birch pollen induced seasonal allergic rhinitis.The study randomised 371 patients into six cumulative dosing regimens plus a placebo, evaluating the change in Total Symptom Score (TSS) following a conjunctival provocation test (CPT) with the objective to achieve a dose recommended for Phase III development.Results summary of the PQBirch 204 Phase II study programme· The primary endpoint, to demonstrate a statistically significant (p<0.01) dose-response for the 5000 standardised units (SU) to 27300 SU, was met. This enables prediction of the dose to enter Phase III development· The study demonstrated a statistically significant (p<0.01) dose-response for the 5000 standardised units (SU) to 27300SU dose range studied· The dose-response closely followed and extended the findings of the previous dose-response study (PQBirch203), which studied doses from 600SU to 13600SU· PQBirch continues to be well-tolerated and no safety concerns were reported in any treatment arm. There was no significant relationship between any adverse drug reaction exhibited and the respective dosage of allergoid· Overall adherence to the dosing regimens was approximately 94% with no relevant differences between treatment arms.Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "The results of the PQBirch204 trial are very encouraging and they reaffirm the potential of our Pollinex platform to treat the underlying cause of allergic rhinitis. Approximately 6% of the population in Europe alone is allergic to birch pollen and there continues to be a need for a safe and well tolerated effective treatment for this significant health issue. Pollinex is the only ultra-short course aluminium-free treatment in the market and its convenience for patients is driving our market penetration in all our European markets. "This study is a significant milestone in our route to Marketing Authorisation and keeps us on track to commence the Phase III study in early 2017."[link]
II Editor
21 Apr 2016
NEW ARTICLE: This list of shares keeps outperforming "While not quite biblical scale, the market's recovery from February's multi-year lows has been nonetheless quite stunning. The @GB:UKX:FTSE 100 is up 16% in just two months, hoisted higher by fading US interest rate fears, better news out of ..."[link]
Baffler
06 Apr 2016
CFO update Netscientific Appoints Ian Postlethwaite as Chief Financial Officer London, UK - 5th April 2016 - NetScientific plc ("NetScientific", AIM:NSCI), the transatlantic biomedical and healthcare technology group, is pleased to announce that Ian Postlethwaite has accepted the role as Chief Financial Officer. Ian will join the Company and the Board as soon as his current employer has appointed a suitable successor and allowed time for an orderly handover. A subsequent announcement detailing Ian's start date will be made in due course. Ian Postlethwaite is currently the Finance Director and Company Secretary of Allergy Therapeutics plc, where he has held the roles since May 2002. Ian previously held senior finance and executive management positions with AFS (1997-2002), Ericsson (1994-1997) and Phillips Electronics (1989-1994). Ian is a Fellow of the Chartered Association of Certified Accountants. He graduated from Aston University in 1985 with a BSc (Hons) in Geological Sciences. Commenting on the appointment, Sir Richard Sykes, Chairman of NetScientific, said: "I am delighted to welcome Ian to NetScientific as our new Chief Financial Officer. His wealth of experience at Board level in raising capital for listed growth companies with international operations in the healthcare sector will be a huge asset to the Company as we move forward with our new focus on digital health, diagnostics and therapeutics. "We very much look forward to working with Ian as he becomes a pivotal member of our team. Until he commences Mark Nanovich will continue in his role as Interim CFO, and we would like to thank Mark for his continued contribution in helping to support the business during our recent period of transition." Ian Postlethwaite commented: "I am excited to be joining NetScientific - this is a rapidly progressing group with an exciting portfolio of high-quality assets focused on dynamic new areas in healthcare. I look forward to working with the team to build value."
Baffler
31 Mar 2016
New note from Edison ups valuation There is a new note from Edison outlining potential game changing catalysts is 2016. It also appears to be increase the potential of Europe.dyor/impoDelivering European growth ahead of the market…AGY is building on a solid revenue base from its European allergy immunotherapy (AIT) franchise, driven by the Pollinex Quattro (PQ) range (£46.6m in FY15). Near-term growth prospects are linked to regional and cross-selling opportunities, notably through Alerpharma in Spain, while expected higher regulation of the European AIT market in the long term could see ahead of market growth rates due to the advanced status of AGY’s products compared with its European peers.…and exploring new avenues…AGY is developing an ultra-short course Acarovac Quattro house dust mite vaccine based on its non-aluminium vaccine adjuvant systems, MCT/MPL (microcrystalline tyrosine/monophosphoryl lipid), while also exploring further potential of MCT (may be licensed for use outside allergies). The share placement in November (41m new shares sold at 28p/share) will also support development of Polyvac Peanut through to Phase I studies (in two to three years) after AGY licensed the Virus Like Particles (VLP) technology from Saiba Biotech; this has the potential for protective immunity from short-course injections vs short-lived protection via daily, long-term treatments.…while seeking to enter the $2bn US marketPQ Grass, known as GrassMATAMPL (GMM) in the US, could be the first licensed seasonal subcutaneous immunotherapy to reach the US market, which could be favoured by physicians vs competitor long-course sublingual products. AGY is fully funded to complete pivotal studies via its £20m March 2015 equity raise, operating cash flow and facilities from the ongoing business, and in December began a 250-pt Phase II chamber study in the US, with results due in H216. Our peak US sales estimate across the PQ range is $1.1bn.Valuation: £274m DCF value = fair value pre-catalystsOur increased £274m (47p/share) base case DCF valuation is conservative, not yet including Acarovac Quattro or Polyvac Peanut, and assuming a 25% royalty on US PQ sales. We note that it is fair value ahead of various potential catalysts in 2016.
Baffler
08 Mar 2016
Re: Interims TV Interview The guys continue to exude confidence and to push the message very strongly.-On track with USA trials-Time lines being kept to with no slippage on various trials.-Expanding portfolio based on unique short course aluminium free approach-"Patient friendly" the new buzz phrase-Money in the bank-Europe performing strongly in flat markets-Balance sheet is strongI also note that they are growing in stature in front of the camera and have hired a leading PR company to expand the messageI expect another note from Edison very soon.impo/dyor
